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NMPA Breakthrough Therapy Designation granted for SHR3680 for the treatment of metastatic hormone-sensitive prostate cancer with high tumor burden

On September 7, 2021 Jiangsu Hengrui Pharmaceuticals Co., Ltd. reported that the China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for SHR3680 in the treatment of metastatic hormone‑sensitive prostate cancer (mHSPC) with high tumor burden (Press release, Hengrui Pharmaceuticals, SEP 7, 2021, View Source [SID1234633499]). The BTD will expedite the development and the following new drug application (NDA) review of this next-generation androgen receptor (AR) antagonist.
The BTD is supported by the latest positive interim data from the Phase III SHR‑3680‑III-HSPC study, a multicenter, randomized, and active-controlled clinical trial evaluating the efficacy and safety of SHR3680 in combination with androgen deprivation therapy (ADT) in mHSPC patients with high tumor burden. The primary endpoint, radiographic progression‑free survival (rPFS) evaluated by Independent Data Monitoring Committee (IDMC), was met. The interim analysis demonstrated that SHR3680 significantly reduced the risk of disease progression or death in mHSPC patients with high tumor burden.

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About the Study

The Phase III SHR-3680-III-HSPC study enrolled 654 patients who were randomized 1:1 to receive either SHR3680 plus ADT or standard of care (SoC) plus ADT from 50 sites in China and 22 sites in East Europe (Portland, Czech Republic, and Bulgaria). This study was initiated in June 2018, and Professor Dingwei Ye from Fudan University Shanghai Cancer Center is the Leading Principal Investigator. The primary endpoints include rPFS based on IDMC evaluation and overall survival (OS). The secondary endpoints include rPFS based on investigator evaluation, time to prostate specific antigen (PSA) progression, safety‑related endpoints and etc.

About Prostate Cancer

Prostate cancer is the second most common type of cancer in men and is the fifth leading cause of cancer mortality worldwide. According to the GLOBOCAN 2020 report, there were approximately 1.41 million new prostate cancer cases (comprising 14.1% of male cancer new diagnoses, after lung cancer which accounts for 14.3%) and approximately 380,000 prostate cancer deaths (comprising 6.8% of male cancer deaths) worldwide in 2020. The incidence of prostate cancer in China is lower than that in Western countries, but it has significantly increased in recent years. In 2015, there were approximately 60,000 new prostate cancer cases and approximately 27,000 prostate cancer deaths in China. However, in 2020, there were approximately 115,000 new prostate cancer cases and approximately 51,000 prostate cancer deaths in China, according to World Health Organization.

About SHR3680

SHR3680 is a proprietary next-generation AR antagonist developed by Hengrui, which is currently in the late stage of clinical development. SHR3680 demonstrated significantly lower extent of brain penetration in pre-clinical studies, which potentially reduces the risks for seizure. Clinical data to date supports this potential advantage over the 2nd‑generation AR antagonists. In addition to the SHR-3680-III-HSPC study which showed positive interim rPFS analysis results, there are multiple SHR3680 clinical studies ongoing to investigate single agent or combination with other drugs (such as docetaxel) in metastatic castration‑resistant prostate cancer.

bluebird bio Announces Key Management and Board Appointments and Upcoming Investor Events

On September 7, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported key management and board appointments in advance of the company’s planned separation, targeted for mid-October, 2021 (Press release, 2seventy bio, SEP 7, 2021, View Source [SID1234594648]). The company also outlined plans for investor events and participation in investor conferences leading up to the separation.

"As we approach separation, we are focused on ensuring that both bluebird bio and 2seventy bio have strong management teams and boards in place to carry each company through its next phase," said Nick Leschly, chief bluebird. "After an intense period of internal work to prepare for the separation, we’re now looking forward to engaging with key external stakeholders to share plans for each company as we near our targeted October separation."

bluebird bio management update

"I’m thrilled to welcome Gina Consylman to the leadership team of bluebird bio. Upon the effectiveness of the planned separation, Gina will become the chief financial officer of bluebird bio," said Andrew Obenshain, president, severe genetic disease. "Her prior experience in a similar spin transaction and helping lead a successful commercial organization through periods of change has already made her an invaluable partner as we move through an important execution phase at bluebird."

Gina Consylman joined bluebird in August 2021 as the CFO of the severe genetic disease business, overseeing finance, tax, accounting, treasury, insurance and investor relations. She has over 25 years of experience in finance, investor relations, strategy and business development. Prior to joining bluebird, she served as senior vice president and CFO at Ironwood Pharmaceuticals. Before Ironwood, Gina served as vice president, corporate controller and principal accounting officer at Analogic Corporation, a publicly-held healthcare and security technology solutions company, where she oversaw the company’s global accounting and treasury teams. Prior to her work at Analogic, Gina served as senior director of corporate accounting at Biogen Inc., where she led the accounting teams for corporate and U.S. commercial business units.

Gina serves on the board of directors for Assembly Biosciences, Inc. and Verastem Oncology. A Certified Public Accountant, Gina began her career in public accounting at Ernst & Young LLP. She holds a B.S. in accounting from Johnson & Wales University and a M.S. in taxation from Bentley University.

bluebird bio board of directors update

"As we approach the launch of 2seventy bio, I’m excited to welcome Marcela Maus to bluebird bio’s board of directors. Upon effectiveness of the planned separation, Marcela will join the board of 2seventy bio," said Nick Leschly. "Marcela’s work as a translational physician-scientist in the field of immunology, particularly as it relates to T-cell immunotherapies and cellular therapies in the treatment of cancer makes her ideally suited to provide valuable insights to the 2seventy team."

Marcela Maus, M.D., Ph.D., is currently an associate professor at Harvard Medical School, the Paula O’Keefe chair in oncology and director of cellular immunotherapy at Mass General Cancer Center, as well as an attending physician in the Hematopoietic Cell Transplant and Cell Therapy division of Oncology at Mass General Cancer Center. She is an associate member of the Broad Institute of Harvard and Massachusetts Institute of Technology (MIT), and an associate member of the Ragon Institute of Mass General Cancer Center, MIT, and Harvard. Dr. Maus’ laboratory focuses on the biology of human T cell activation, costimulation, and memory, and on the application of human T cell therapies to human disease, including forward and reverse translation of engineered T cell therapies in early-phase clinical trials.

Dr. Maus completed undergraduate studies at MIT and holds graduate degrees (M.D., Ph.D.) from the University of Pennsylvania. Dr. Maus trained in internal medicine at the University of Pennsylvania and in hematology and medical oncology at Memorial Sloan Kettering Cancer Center, is board-certified in these three disciplines, and practices medical oncology. She also serves on several scientific and clinical advisory boards for the biotechnology industry as well as external academic medical centers.

Upcoming investor events

Members of the management teams of bluebird bio and 2seventy bio will participate in the following upcoming investor conferences:

Morgan Stanley 19th Annual Healthcare Conference
bluebird bio: September 10, 2021 at 10:15am ET
2seventy bio: September 9, 2021 at 12:30pm ET
Bank of America Global Healthcare Conference 2021
bluebird bio: September 16, 2021 at 9:10am ET
2seventy bio: September 17, 2021 at 10:05am ET

Gritstone Announces Presentations at Two Investor Conferences in September

On September 27, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported that Gritstone management will present webcasted company overviews at two upcoming investor conferences in September (Press release, Gritstone Oncology, SEP 7, 2021, View Source [SID1234592011]).

Conference: H.C. Wainwright 23rd Annual Global Investment Conference
Date and Time: Monday, September 13, 2021 at 7:00 a.m. ET
Presenter: Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer

Conference: Cantor Virtual Global Healthcare Conference
Date and Time: Wednesday, September 29, 2021 at 2:40 p.m. ET
Presenter: Celia Economides, executive vice president and chief financial officer

A live webcast of the presentations will be accessible via the Investors & Media section of the company’s website at View Source An archived replay will be accessible for 30 days following each event.

ALX Oncology Announces Upcoming Virtual Investor Conference Participation

On September 7, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two upcoming virtual investor conferences (Press release, ALX Oncology, SEP 7, 2021, View Source [SID1234591863]).

H.C. Wainwright 23rd Annual Global Investment Conference
Format: Fireside chat with analyst, Swayampakula Ramakanth
Date: Monday, September 13
Time: 7:00 AM Eastern Time
Webcast link: Available here

Cantor Virtual Global Healthcare Conference
Format: Fireside chat with analyst, Alethia Young
Date: Tuesday, September 28
Time: 11:50 AM Eastern Time
Webcast link: Available here

A live webcast of the fireside chats can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcasts will be archived for up to 90 days following the fireside chat dates.

SpringWorks Therapeutics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 7, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in the H.C. Wainwright 23rd Annual Global Investment Conference (Press release, SpringWorks Therapeutics, SEP 7, 2021, View Source [SID1234591666]). A webcast of the company presentation will be available on-demand starting Monday, September 13, 2021 at 7:00 am ET.

To access the webcast, please visit the "Events & Presentations" page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.